ChloraPrep Versus Betadine for Elective Knee Replacement Surgery

NCT01184196 | Terminated Phase 4

• 1 other identifier: 10-008
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This study will enroll patients who will be receiving primary total knee replacements. Subjects will be randomized into two groups: Betadine surgical scrub preparation and ChloraPrep preparation prior to total knee replacements. Study hypothesis: When used as a surgical scrub preparation prior to primary total knee arthroplasties, ChloraPrep (2% chlorhexadine gluconate and 70% isopropyl alcohol) is superior to Betadine (10% povidone iodine) in reducing incision site bacterial colony counts.

Conditions

Arthroplasty, Knee Replacement; Replacement, Total Knee; Total Knee Replacement

Keywords

knee replacement; knee arthroplasty; total knee replacement; arthroplasty, knee replacement

Outcome Measures

Primary Outcomes (1)

• Quantitative bacterial colony counts for aerobic and anaerobic culture swabs will be taken at 3 timeperiods to determine if ChloraPrep is superior to Betadine in reducing incision site bacterial colony counts.

  Subjects scheduled to undergo primary total knee arthroplasty will be randomized to receive either a Betadine surgical scrub or ChloraPrep surgical scrub at the time of surgery. Subjects will be enrolled until swab #3 is obtained, 24 hours post-surgery.

  24 hours

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Subjects randomized to Arm 1 will receive Betadine surgical scrub at the time of primary total knee arthroplasty.

Drug: Swab area with Betadine

Arm 2

ACTIVE COMPARATOR

Subjects in Arm 2 will receive ChloraPrep surgical scrub prior to elective primary total knee arthroplasty.

Drug: Swab area with ChloraPrep

Interventions

Swab area with Betadine DRUG

A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery.

Also known as: Povidone Iodine

Arm 1

Swab area with ChloraPrep DRUG

A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery.

Also known as: Chlorhexadine Gluconate

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo primary total knee arthroplasty
• Age 18 or over

You may not qualify if:

• Inability to provide informed consent or to comply with study assessments due to cognitive impairment or geographic distance
• Age 17 or younger
• Allergies to chlorhexadine gluconate or povidone iodine
• Topical antimicrobial use within 14 days of surgery
• Any active dermatoses or open wounds over the operative site
• Any condition requiring antibiotics 14 days prior to arriving for surgery
• Patients with chronic immunosuppression (such as HIV/AIDS)
• Unable to adhere to follow up schedule and treatment

Sponsors & Collaborators

• Central DuPage Hospital: lead

Study Sites (1)

Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

Related Publications (8)

• Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.

  PMID: 15866959 BACKGROUND

• Edwards PS, Lipp A, Holmes A. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2004;(3):CD003949. doi: 10.1002/14651858.CD003949.pub2.

  PMID: 15266508 BACKGROUND

• Aly R, Maibach HI. Comparative antibacterial efficacy of a 2-minute surgical scrub with chlorhexidine gluconate, povidone-iodine, and chloroxylenol sponge-brushes. Am J Infect Control. 1988 Aug;16(4):173-7. doi: 10.1016/0196-6553(88)90029-6.

  PMID: 3189943 BACKGROUND

• Kaul AF, Jewett JF. Agents and techniques for disinfection of the skin. Surg Gynecol Obstet. 1981 May;152(5):677-85. No abstract available.

  PMID: 7013126 BACKGROUND

• Grabsch EA, Mitchell DJ, Hooper J, Turnidge JD. In-use efficacy of a chlorhexidine in alcohol surgical rub: a comparative study. ANZ J Surg. 2004 Sep;74(9):769-72. doi: 10.1111/j.1445-1433.2004.03154.x.

  PMID: 15379808 BACKGROUND

• Nishimura C. Comparison of the antimicrobial efficacy of povidone-iodine, povidone-iodine-ethanol and chlorhexidine gluconate-ethanol surgical scrubs. Dermatology. 2006;212 Suppl 1:21-5. doi: 10.1159/000089195.

  PMID: 16490971 BACKGROUND

• Geelhoed GW, Sharpe K, Simon GL. A comparative study of surgical skin preparation methods. Surg Gynecol Obstet. 1983 Sep;157(3):265-8.

  PMID: 6612574 BACKGROUND

• Keblish DJ, Zurakowski D, Wilson MG, Chiodo CP. Preoperative skin preparation of the foot and ankle: bristles and alcohol are better. J Bone Joint Surg Am. 2005 May;87(5):986-92. doi: 10.2106/JBJS.D.02695.

  PMID: 15866960 BACKGROUND

Related Links

• Midwest Ortho at RUSH

MeSH Terms

Interventions

Povidone-Iodine

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Scott Sporer, MD

  Midwest Orthopaedics at Rush

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 18, 2010
• Study Start: November 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 16, 2013

Record last verified: 2013-04

Locations

US (1)